Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments

Bronchiolitis is one of the most common causes of hospital admission in infants during the winter season. Although respiratory symptoms are usually the main concern, some infants present with a predominantly nutritional phenotype characterized by a marked reduction in feeding or feeding refusal. These infants may require enteral nutritional support even when they do not have severe respiratory failure or other established risk factors for severe bronchiolitis.

Under current practice, the need for enteral nutrition generally results in hospital admission, either to a pediatric short-stay unit or to a conventional inpatient ward. However, hospital capacity is frequently under considerable pressure during respiratory syncytial virus epidemics. Systematic admission of infants who mainly require temporary nutritional support may contribute to bed shortages, inter-hospital transfers, prolonged waiting times, and organizational difficulties for families and healthcare teams.

The Short-Term Enteral Nutrition Protocol in the Pediatric Emergency Room (STENP-PER) was developed as an alternative care pathway for carefully selected infants with bronchiolitis and predominant nutritional insufficiency. The programme aims to provide early nutritional treatment and clinical monitoring directly in the pediatric emergency department, while avoiding conventional hospital admission when the infant's condition permits safe discharge home.

A preliminary feasibility and proof-of-concept study conducted in Lyon suggested that a six-hour enteral nutrition pathway in the pediatric emergency department was feasible and was positively perceived by families and healthcare professionals. The preliminary findings also suggested that most clinical deteriorations requiring hospital admission occurred during the initial monitoring period and that hospital admissions following discharge mainly occurred during the first few days. These findings supported the selection of a 14-day follow-up period for the present study.

STENP-PER is a multifaceted intervention that combines a standardized clinical care pathway with measures intended to support its implementation. Its main components include education and training of medical and paramedical staff, standardized tools to support delivery of the pathway, and implementation facilitation adapted to the organization and resources of each participating department.

During the intervention period, the infant is cared for in a bed in the pediatric emergency department, with a parent present whenever possible. A trained pediatric nurse inserts a nasogastric tube and initiates six hours of continuous enteral nutrition using an enteral feeding pump. The infant's general condition, respiratory status, vital signs, feeding tolerance, and any adverse events are monitored throughout the procedure.

Parents receive therapeutic education, including information about the benefits and potential risks of nasal clearance, a practical demonstration, and supervised practice when appropriate. Participating departments may provide additional education according to their usual practices and priorities, e.g. advice on safe sleeping and the prevention of exposure to tobacco smoke.

At the end of the six-hour period, the infant is clinically reassessed. Infants whose condition is compatible with discharge return home with instructions concerning monitoring, reasons for seeking further medical care, and contact details for the pediatric emergency department. If the infant develops signs requiring hospital monitoring or treatment, the care pathway is converted to conventional hospital admission. Clinical decisions remain under the responsibility of the treating team, and the procedure may be modified, slowed, interrupted, or stopped whenever necessary for the infant's safety.

The comparator is the current usual-care strategy. During control periods, infants who require nasogastric enteral nutritional support are admitted to a pediatric short-stay unit or conventional inpatient ward. Enteral nutrition and clinical monitoring are then provided in accordance with the usual procedures of each participating hospital.

The effectiveness of the STENP-PER programme will be evaluated using a multicentre, cluster-randomized stepped-wedge superiority design. The unit of randomization is the pediatric emergency department rather than the individual infant because the intervention involves changes in professional practice, staff training, task organization, and the local care pathway. Individual randomization within the same department would create a substantial risk of contamination between the two strategies.

Eight pediatric emergency departments in France will participate. The study will be conducted over four consecutive annual respiratory syncytial virus epidemic seasons. During the first period, all participating departments will provide usual care. The departments will then switch progressively to the STENP-PER programme according to a randomized implementation sequence. Three departments will switch to the intervention during the second period, three during the third period, and the remaining two during the fourth period. Once a department has implemented STENP-PER, it will continue to use the programme during subsequent study periods.

The order of implementation will be generated by the Biostatistics Department of Hospices Civils de Lyon. Training and local preparation will take place between epidemic seasons before each department begins its intervention period. Because every department contributes observations during both control and intervention periods, each department acts as its own control. This design helps account for differences between hospitals in activity levels, available resources, patient populations, organizational characteristics, and usual practices.

Recruitment will be restricted to the respiratory syncytial virus epidemic period at each participating centre. The beginning and end of each recruitment period will be determined using information from the hospital virology laboratory or regional indicators provided by Santé publique France. Fourteen infants will be enrolled per centre during each epidemic season, resulting in a total anticipated sample of 448 participants.

Each participant will be followed from inclusion through Day 14. Clinical and healthcare-use information will be collected from the medical record, hospital data systems, and a telephone interview with the parents around Day 14. The telephone follow-up will be used to document the infant's clinical course, any subsequent medical consultations, hospitalizations or rehospitalizations, the parents' experience of care, and their understanding of the information provided during the initial visit.

The primary analysis will compare the cumulative number of hospitalization days through Day 14 between the STENP-PER and usual-care strategies. All hospital stays associated with the initial episode will be considered, including immediate admission following the index emergency department visit and any subsequent hospitalization or rehospitalization related to worsening bronchiolitis or a complication of its management.

Additional analyses will evaluate the effects of the programme on immediate hospital admission, inter-hospital transfer, parent satisfaction and experience, parental knowledge, healthcare professional satisfaction, safety, and tolerance. Adverse events of particular interest include persistent nutritional insufficiency, the development of respiratory failure, nasogastric tube displacement or removal, and aspiration. Safety events will be reviewed and classified using standardized procedures established by the study's Event Validation Committee.

The study also includes an implementation evaluation guided by the integrated Promoting Action on Research Implementation in Health Services framework. External facilitators from the Lyon expert centre will work with local medical and paramedical facilitators in each participating department. This process will support the adaptation of the programme to the local context while preserving its essential clinical components.

Implementation will be evaluated in terms of fidelity, acceptability, sustainability, and transferability. Service-level fidelity will describe whether the programme components were implemented as planned. Participant-level fidelity will assess compliance with the intended duration and flow rate of enteral nutrition, completion of parent education, and reasons for deviations from the pathway. The proportion of eligible infants who receive STENP-PER during intervention periods will also be examined.

Acceptability, barriers, and facilitating factors will be explored from the perspectives of healthcare professionals and parents. Focus groups or individual interviews will be conducted with healthcare professionals and local facilitators in each participating department. Semi-structured interviews will also be proposed to approximately 14 to 20 parents who experienced the intervention. These interviews will explore their experience of the care pathway, their perception of safety, their acceptance of early discharge, and the organizational or personal factors that may influence implementation.

The transferability evaluation will examine whether the programme developed at the Lyon expert centre can be adapted and implemented in pediatric emergency departments with different organizational contexts. Information from implementation follow-up, professional focus groups, parent interviews, participant characteristics, fidelity indicators, and programme maintenance will be combined to identify the conditions required for wider deployment.

A health-economic evaluation will compare the costs of STENP-PER with those of usual inpatient care from the perspective of the healthcare system over the 14-day follow-up period. The cost of the intervention pathway will be estimated using a micro-costing approach that includes staff time and the consumables required for the procedure. Other healthcare costs will include emergency department care, initial hospitalization, transfers, and rehospitalizations. This evaluation will determine whether the new pathway can reduce resource use and costs while maintaining safe and appropriate care.

The study uses a hybrid effectiveness-implementation design because the clinical effect of STENP-PER may depend on how successfully the programme is introduced into routine practice. The effectiveness, safety, implementation, and economic findings will therefore be interpreted together. This combined approach is intended to determine not only whether STENP-PER reduces hospital use, but also under which organizational conditions it can be safely maintained and transferred to other pediatric emergency departments.